Pedro Monteleone
JBRA Assist. Reprod. 2026; 30 (2):417-418
Received June 27, 2025
Accepted June 05, 2026
Abstract
Reproductive immunology has emerged as a promising field, yet many of its clinical applications lack rigorous scientific validation. Despite their widespread use, interventions such as intravenous immunoglobulin (IVIG), corticosteroids, lymphocyte immunotherapy, and uterine natural killer (NK) cell testing are frequently adopted without adherence to the standards of evidence-based medicine. Unlike pharmaceutical drugs and diagnostic tools, these therapies often bypass structured clinical evaluation, relying instead on observational studies or biologically plausible rationale. This trend, criticized by researchers such as Gleicher et al., reflects a broader issue: the prioritization of theoretical mechanisms over robust clinical evidence. Compounding this problem are commercial pressures from the fertility industry and a lack of regulatory oversight, which allow unproven interventions to persist. Examples include the Endometrial Receptivity Analysis (ERA®), intrauterine platelet-rich plasma (PRP), and intralipid infusions—all lacking consistent data supporting clinical efficacy. This commentary calls for the implementation of strict validation standards in reproductive immunology to ensure ethical, effective, and scientifically sound patient care.